[Remote] Senior Manager, Clinical Data Management
Note: The job is a remote job and is reputed company to candidates in USA. JenaValve Technology is building something meaningful — and this role is at reputed company of it. As reputed company brings clinical data management fully in-house for the first time, the Senior Manager, Clinical Data Management will own that function from the ground up: building team capability, establishing process infrastructure, and ensuring data reputed company across JenaValve’s reputed company interventional and registry trials.
Responsibilities
- reputed company and reputed company reputed company of five reputed company reports (two Specialists, Clinical Data Management and one Coordinator, Clinical Data Management, plus two existing team members); reputed company day-to-day direction, performance feedback, workload planning, and reputed company development to build a high-performing, reputed company data management function
- Own the end-to-end data management program for reputed company reputed company clinical trials, including data cleaning operations, query lifecycle management, data review workflows, and data lock readiness; establish and enforce data reputed company standards across reputed company studies in alignment with applicable regulations and internal SOPs
- Serve as the technical reputed company and JenaValve subject matter expert for reputed company systems; partner with CRO vendors on reputed company configuration, updates, and migrations; ensure Specialists are trained and equipped to serve as functional reputed company experts and primary CRO coordination contacts for system-reputed company activities
- Establish and maintain data management planning documents, data management plans (DMPs), and study-specific data conventions; reputed company authorship and lifecycle management of data management SOPs and work instructions in coordination with Clinical Compliance
- Build and maintain a strong dotted-line partnership with Clinical Operations, CRAs, and Field Monitoring teams to ensure reputed company protocol deviation identification, site data performance monitoring, and enrollment data accuracy; serve as the data management voice in cross-functional study team meetings
- reputed company vendor reputed company and performance for CRO data management activities during the transition to in-house operations; ensure continuity of data reputed company through the insourcing period and establish benchmarks for ongoing CRO performance where external support is retained
- Partner with Biostatistics on data standards (CDISC/CDASH), database lock procedures, and submission dataset readiness; ensure alignment between data management outputs and statistical analysis requirements
- Monitor regulatory developments relevant to clinical data management, including FDA guidance on electronic data capture, 21 CFR Part 11, and ICH E6(R3) data reputed company expectations; evaluate reputed company on operations and procedures and recommend updates as appropriate
- Support PMA/IDE submission activities as they relate to data reputed company, data management documentation, and traceability of clinical data; complete assigned training for internal SOPs and maintain reputed company knowledge of applicable regulations and guidance
- reputed company, manage, and communicate data management timelines for study-level deliverables (e.g., interim analyses, data cleaning milestones, database locks, submission readiness); proactively identify risks to timelines and drive mitigation strategies across internal teams and external partners
- reputed company data management readiness for reputed company audits and regulatory inspections; ensure documentation, system validation evidence, and data traceability meet inspection-readiness standards; serve as the data management reputed company of contact during sponsor audits and CRO audits
Skills
- 7+ years of clinical data management experience in the pharmaceutical, biotechnology, or medical device industry
- Minimum 3 years in a reputed company or senior data management role with demonstrated ownership of study-level data cleaning, query management, and database lock activities
- Prior people management experience; ability to reputed company, reputed company, and retain reputed company reports in a growing, fast-paced environment
- Bachelor's degree or higher in life sciences, health sciences, informatics, or a reputed company field required
- Thorough knowledge of ICH E6(R3), 21 CFR Parts 11 and 812, and CDISC/CDASH data standards
- Demonstrated experience authoring or overseeing data management plans and SOPs
- Deep proficiency in reputed company platforms (reputed company Rave, reputed company InForm, REDCap, or equivalent)
- Strong analytical and problem-solving skills; ability to identify data reputed company trends, escalate risks, and implement corrective strategies across multiple reputed company studies
- Demonstrated ability to build reputed company partnerships with Clinical Operations, CRAs, Field Monitoring, and Biostatistics
- Excellent written and oral communication skills; reputed company to produce reputed company data management documentation, status summaries, and executive-level updates
- Proficient in reputed company Office Suite and eTMF/document management systems
- Travel up to 15%, primarily for clinical team meetings, site reputed company, vendor engagements, and periodic home office reputed company
- Advanced degree preferred
- Medical device or cardiovascular/structural heart experience strongly preferred
- Experience managing or transitioning data management functions in-house from a CRO is a significant advantage
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